| | | | | | | | | | |
|
| |
|
| Dockets Entered
On July 9, 2004
Table of Contents
|
|
|
|
|
|
|
|
|
|
|
| Docket #
|
| Title
|
|
|
|
|
|
|
| 1995S-0316
|
| 75-Day Premarket Notifications for New Dietary Ingredients
|
|
|
|
|
| 1999F-0719
|
| Safe use Olestra in place of Fats and Oils in Prepackaged
|
|
|
|
|
| 2000N-1571
|
| Enrofloxacin for Poultry: Opportunity for Hearing
|
|
|
|
|
| 2002P-0520
|
| Reclassification of Beta-Tricalcium Phosphate,
|
|
|
|
|
| 2003E-0251
|
| Patent 5,667,787, Daptacel (Diphtheria & Tetanus Toxoids & Acellular Pertussis Vaccine)
|
|
|
|
|
| 2003E-0257
|
| Patent Extension for Neotame, 5,480,668
|
|
|
|
|
| 2003E-0405
|
| Patent Term Restoraton Application for Neutersol (zinc gluconate), U.S. Patent No. 5,070,080
|
|
|
|
|
| 2003E-0452
|
| Patent Extension, Neutersol, zinc gluconate, Patent No. 4,937,234
|
|
|
|
|
| 2004D-0178
|
| Guidance for Industry and FDA Staff; Draft Class II Special Controls Guidance Document: Dental Bone Grafting Material; Availability
|
|
|
|
|
| 2004M-0203
|
| BP030025 / 0 Trinity Biotech Uni-Gold Recombigen HIV, Uni-Gold Recombigen HIV Positive and Negative Controls
|
|
|
|
|
| 2004P-0280
|
| ANDA for Nicotine Polacrilex, 2 mg base per 240 mL oral solution
|
|
|
|
|
| 2004P-0281
|
| Nicotine Base Oral Solution 2 mg base per 240 mL oral solution and 4 mg base per 240 mL oral solution in bottles
|
|
|
|
|
| 2004P-0282
|
| Nicotine Bitartrate Oral solution 2 mg base per 240 mL oral solution and 4 mg base 240 mL oral solution in bottles
|
|
|
|
|
| 2004V-0292
|
| Laser Light Show
|
|
| |
|
| 1995S-0316
|
| 75-Day Premarket Notifications for New Dietary Ingredients
|
|
|
| RPT
189
Attachments
|
| Loders Croklann B.V.
|
| Vol #:
|
| 139
|
|
|
|
|
| RPT
190
Notification
Report
Appendices
References
|
| ProNutrient Technologies, Inc
|
| Vol #:
|
| 140
|
|
|
|
|
| RPT
191
Attachment
|
| Nokomis Research Inc
|
| Vol #:
|
| 141
|
|
|
|
|
| RPT
192
Attachment
|
| ISC (Innovative Supplement Concepts)
|
| Vol #:
|
| 141
|
|
|
|
|
| RPT
193
Attachment
|
| New Cewntury Company
|
| Vol #:
|
| 141
|
|
|
|
|
| 1999F-0719
|
| Safe use Olestra in place of Fats and Oils in Prepackaged
|
|
|
|
|
| NCR
1
|
| FDA
|
| Vol #:
|
| 1
|
|
|
|
|
| 2000N-1571
|
| Enrofloxacin for Poultry: Opportunity for Hearing
|
|
|
|
|
| EXB 242
|
| Center for Veterinary Medicine
|
| Vol #:
|
| 419
|
|
|
|
|
| EXB 243
|
| Center for Veterinary Medicine
|
| Vol #:
|
| 419
|
|
| |
|
| 2002P-0520
|
| Reclassification of Beta-Tricalcium Phosphate,
|
|
|
|
|
| BKG 2
|
| Background Information References 1-5
|
| Vol #:
|
| 1
|
|
|
|
|
| NPR
1
|
| FDA
|
| Vol #:
|
| 1
|
|
|
|
|
| 2003E-0251
|
| Patent 5,667,787, Daptacel (Diphtheria & Tetanus Toxoids & Acellular Pertussis Vaccine)
|
|
|
|
|
| N
1
|
| FDA
|
| Vol #:
|
| 1
|
|
|
|
|
| 2003E-0257
|
| Patent Extension for Neotame, 5,480,668
|
|
|
|
|
| N
1
|
| FDA
|
| Vol #:
|
| 1
|
|
| | | | | | | | |
|
|
|
|
| 2003E-0405
|
| Patent Term Restoraton Application for Neutersol (zinc gluconate), U.S. Patent No. 5,070,080
|
|
|
|
|
| N
1
|
| FDA
|
| Vol #:
|
| 1
|
|
|
|
|
| 2003E-0452
|
| Patent Extension, Neutersol, zinc gluconate, Patent No. 4,937,234
|
|
|
|
|
| N
1
|
| FDA
|
| Vol #:
|
| 1
|
|
| |
|
| 2004D-0178
|
| Guidance for Industry and FDA Staff; Draft Class II Special Controls Guidance Document: Dental Bone Grafting Material; Availability
|
|
|
|
|
| GDL
1
|
| Guidance
|
| Vol #:
|
| 1
|
|
|
|
|
| NAD
1
|
| FDA
|
| Vol #:
|
| 1
|
|
|
|
|
| 2004M-0203
|
| BP030025 / 0 Trinity Biotech Uni-Gold Recombigen HIV, Uni-Gold Recombigen HIV Positive and Negative Controls
|
|
|
|
|
| N
1
|
| FDA
|
| Vol #:
|
| 1
|
|
|
|
|
| 2004P-0280
|
| ANDA for Nicotine Polacrilex, 2 mg base per 240 mL oral solution
|
|
|
|
|
| ACK
1
|
| HFA-305 to Nico Worldwide, LLC
|
| Vol #:
|
| 1
|
|
|
|
|
| 2004P-0281
|
| Nicotine Base Oral Solution 2 mg base per 240 mL oral solution and 4 mg base per 240 mL oral solution in bottles
|
|
|
|
|
| ACK
1
|
| HFA-305 to Nico Worldwide, LLC
|
| Vol #:
|
| 1
|
|
|
|
|
| 2004P-0282
|
| Nicotine Bitartrate Oral solution 2 mg base per 240 mL oral solution and 4 mg base 240 mL oral solution in bottles
|
|
|
|
|
| ACK
1
|
| HFA-305 to Nico Worldwide, LLC
|
| Vol #:
|
| 1
|
|
|
|
|
| 2004V-0292
|
| Laser Light Show
|
|
|
|
|
| ACK 1
|
| HFA-305 to Arctic Ice Arena
|
| Vol #:
|
| 1
|
|
|
|
|
| VAR
1
|
| Arctic Ice Arena
|
| Vol #:
|
| 1
|
|
